Hand Sanitizer Regulations
Hand sanitizer regulations vary with each country; in the US, FDA regulate antiseptic hand sanitizer as an OTC Monograph Drug. In most other countries, Hand sanitizer comes under cosmetic regulations which require labeling compliance and complying with ISO 22716:2007- Good Manufacturing Practice for cosmetics.
FDA Regulations for Hand Sanitizer
FDA regulations for hand sanitizer is same as all other OTC Monograph drugs. The FDA requirements are
1. US FDA Registration – Register the manufacturing establishment with FDA.
2. NDC Labeler code – Request a labeler code for the establishment or Company.
3. Hand sanitizer listing with FDA – Assign a unique 10-digit NDC number and List each hand sanitizer with FDA.
4. Label Compliance – Antiseptic hand sanitizer must have "Drug Facts" labeling and all other required information's.
5. Comply with GMP Requirements as per 21 CFR 211.
6. Comply with OTC Monogrpah – The eligible active ingredients in the OTC Monograph are
- Benzalkonium chloride
- Ethyl alcohol or Ethanol ( 60 to 95 percent)
- Isopropyl alcohol (70 to 91.3 percent)
If you are looking for antiseptic Hand Sanitizer regulations or assistance with FDA registration, LMG can assist you.
LMG assist foreign and domestic hand sanitizer manufacturers to register with FDA , we also provide drug listing service and US FDA Agent service to foreign drug establishments. Please complete our online form to register your establishment with FDA.
LMG issue free FDA registration certificate after successfully completing your establishment registration with FDA. You can use this as a proof of FDA registration to the industry, also you can verify certificate validity on our website.